STOCKHOLM, Feb. 11, 2021 /PRNewswire/ -- Dagens Medicin
is critizing in an article on February 10,
2021 one of the clinical studies, the so called ColdPrev I,
which is part of the clinical evaluation data supporting the
benefits of the product, that Enzymatica uses in the marketing of
ColdZyme®. Enzymatica refuses the criticism and gives the comment
below.
ColdZyme is a very well-documented product, whose effect on
common cold has been verified in both in vitro studies as
well as in vivo studies. An in vitro study from 2017
showed that ColdZyme could deactivate over 90% of the known viruses
that cause common colds. The ColdPrev I study, two German
multicenter studies and lately a British study of endurance
athletes display the clinical benefits of ColdZyme.
In the study that Dagens Medicin addresses, ColdPrev I, the
scientists together with experienced statisticians have performed
explorative analysis based on data from the study. These analysis,
and the criterias for the analysis that were used, have been
reviewed and approved by the principal investigator for the study.
These results show that for those participants, which had common
cold symptoms, the duration of the common cold was reduced by up to
3.5 days. Enzymatica considers that data and criterias for the
analysis have been communicated in a clear and transparent way. In
the latest British study on endurance athletes it was also shown
that the duration of the common cold could be shortened by up to
3.5 days.
ColdZyme was recertified in 2020 according to MDD (Medical
Device Directive) by the notified body Eurofins Product Testing.
ColdZyme can thereby be sold as class III medical device product
within the EU. ColdZyme and its documentation have been reviewed by
Eurofins, which is a notified body for medical device products
appointed by a competent authority within the EU. Eurofins have
reviewed the full documentation, which includes safety, efficacy
and product claims.
ColdZyme has contributed in a positive way to the common cold
category in Sweden and
internationally by adding a large group of loyal consumers. We look
forward to continuing our effort to create value within the
category by marketing of a safe, efficient and well-documented
product.
For more information, please contact:
Claus Egstrand, Chief Operating Officer Enzymatica AB
Phone: +44 7780 22 8385 | E-mail: claus.egstrand@enzymatica.com
Ann-Christine Provoost, Director
of Regulatory Affairs Enzymatica AB
Tel: +46 (0) 702-74 37 31 | E-post:
ann-christine.provoost@enzymatica.com
Carl-Johan Wachtmeister,
Communication manager Enzymatica AB
Phone: +46 (0)701-88 50 21 | Email:
carl-johan.wachtmeister@enzymatica.com
About Enzymatica AB
Enzymatica AB is a Swedish life science company that develops
and sells health care products for primarily conditions of the
ear-nose-and-throat region. The products are based on a barrier
technology that includes marine enzymes. The company's first
product is the medical device ColdZyme®, a mouth spray against
common cold. The product has been launched in about 30 markets on 3
continents. The strategy is to continue to grow by developing more
health care products and strengthening the company's position in
existing markets and expanding into new geographic markets through
established partners. The company has its headquarters in
Lund and is listed on Nasdaq First
North Growth Market. For more information,
visit: www.enzymatica.com and
www.enzymatica.se/en/section/media/press-releases
Enzymatica's certified adviser is Erik Penser
Bank. Phone: +46 (0)8 463 83 00.
Email: certifiedadviser@penser.se
Enzymatica AB Ideon Science Park, SE-223 70
Lund, Sweden Telefon
+46 46-286 31 00
This information was brought to you by Cision
http://news.cision.com
https://news.cision.com/enzymatica-ab/r/enzymatica-comments-on-article-in-dagens-medicin,c3285396
The following files are available for download:
https://mb.cision.com/Main/18091/3285396/1371839.pdf
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